Kornimate/medical-research-clean huggingface dataset:
ubiquitous healthcare service with multifactorial intervention in diabetes care

Conditions: Diabetes Mellitus With Hypoglycemia

Summary: recently, we generated a new multidisciplinary ubiquitous healthcare system by upgrading our clinical decision supporting system (cdss) rule engine, and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. we hypothesize that individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback will result in better glucose control with less hypoglycemia in an elderly population.

the use of telemedicine (also known as connected health, e-health, or telehealth) has been proven to be beneficial in chronic disease management. now, the classic concept of telemedicine has been evolving to ubiquitous (u)-healthcare system with advanced information technologies which provides real-time individualized feedback using a monitoring device attached to the internet or a mobile phone system. a few studies showed that adopting a u-healthcare system helped patients improve their blood glucose control and reduced hypoglycemia or weight gain. in a previous study, supervised telemonitoring was effective for blood pressure control in hypertensive patients in primary care settings. a recent study showed that telemonitoring with pharmacist's help achieved better blood pressure control compared with usual care during 12 months of intervention. a clinical decision support system (cdss) is the key to this system, building up an individualized cdss rule engine is the crux of the u-healthcare system because current glucose control status, antidiabetic medications, lifestyle, and severity of hypoglycemia vary between individual patients. recently, our u-healthcare team generated a new multidisciplinary u-healthcare system by upgrading the cdss rule engine, and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. with this integrated system, we investigate the effect of individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control with less hypoglycemia in korean elderly population.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * glycated hemoglobin (hba1c) levels: 7.0-10.5% exclusion criteria: * patients who were unable to use text messages or to access the internet for any reason

Keywords: telemedicine clinical decision support system ubiquitous healthcare diabetes care multifactorial intervention
study of morphine in postoperative infants to allow normal ventilation

Conditions: Infant, Newborn, Diseases; Pain

Summary: objectives: i. compare nonmechanically ventilated infants who receive morphine postoperatively as intermittent intravenous bolus doses or as a continuous intravenous infusion targeted to reach a steady-state concentration. ii. assess ventilation (blood gases, continuous oximetry, and co2 response curves) and analgesia (infant pain score) between the two treatment groups of infants. iii. compare ventilation parameters (blood gases, co2 response curves, and time to wean from assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.

protocol outline: this is a two part study. infants are stratified by age (1-30 days vs 31-180 days vs 181-365 days) and by type of surgery. infants are randomly assigned to one of two treatment arms. in part i, following major thoracic, abdominal, or cardiac surgery, infants are randomized to receive either continuous iv morphine infusions (arm i) or to receive morphine by single iv bolus doses every 2-3 hours (arm ii). in part ii, cyanotic and acyanotic infants following thoracotomy receive morphine by 2 loading doses over 15 minutes and then by continuous iv infusion. patients are followed for at least 2 days. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * infants scheduled for surgery with postoperative inpatient care * must be born after 35 weeks or more gestational age * no prenatal opiate exposure part i patients: * less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures * no pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects) * no hepatic or renal transplantation part ii patients: * less than 3 months of age undergoing surgeries using a thoracotomy approach * cyanotic congenital heart disease having palliative systemic to pulmonary artery shunts created or thoracotomy for repair of acyanotic lesions (e.g., repairs of coarctation of the aorta, tracheoesophageal fistula repair, pda ligation) --patient characteristics-- * age: part i: less than 12 months part ii: less than 3 months * hepatic: normal hepatic function tests * renal: normal renal function tests * pulmonary: no pulmonary disease causing baseline hypercarbia * no pulmonary hypertension contraindicating use of 5% co2 in rebreathing studies other: * no allergy to morphine * no severe developmental delay that precludes analgesia scoring

Keywords: disease-related problem/condition pain intraoperative/postoperative complications rare disease
a multicenter study to assess response to covid-19 vaccine in multiple sclerosis participants treated with ofatumumab

Conditions: Relapsing Multiple Sclerosis

Summary: this is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. fully vaccinated participants must be able to complete immune assay no.1 ≥ 14 days after the second dose of vaccine


Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained prior to participation in the study 2. age 18-55 years old inclusive at screening 3. diagnosis of relapsing ms by 2017 revised mcdonald criteria 4. must be willing to comply with the study schedule 5. have received/scheduled vaccination with a fda approved for emergency use covid-19 mrna vaccine (either pfizer or moderna) (i) either been scheduled for vaccine, (ii) received a single vaccine with a scheduled second dose, or (iii) already completed full course (two dose) vaccination. 6. currently receiving ofatumumab for the treatment of rms (preoftumumab serology with hepatitis b testing showing no active or latent infection, as well as serum igg results to be recorded in the database if available) exclusion criteria: 1. known clinical diagnosis of covid-19 prior to screening based on investigator's or patient's personal physician's judgement 2. has a contraindication to receiving an mrna covid-19 vaccine 3. has an immediate allergic reaction to past vaccine or injection 4. any safety finding including low igg and/or low igm levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to vaccination as determined by the hcp 5. any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit 6. prior treatment with s1p agent within 2 months of study enrollment 7. prior treatment with natalizumab within 6 months of study enrollment 8. contraindications to ofatumumab treatment as per the uspi will be adhered to which include active infection hepatitis b infection, progressive multifocal leukoencephalopathy and pregnancy. 9. participation in another interventional clinical trial within 14 days before enrollment. 10. have been treated with any of the medications as described in the full protocol 11. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after stopping medication

Keywords: covid-19 vaccine ofatumumab sars-cov2 antibody open-label
effect of cervicothoracic mobilization on upper crossed syndrome

Conditions: Upper Crossed Syndrome

Summary: purpose: to investigate the effect of cervicothoracic mobilization on craniovertebral angle (cva), sagittal shoulder angle (ssa), kyphotic angle and pain intensity level in upper crossed syndrome.

upper crossed syndrome and its associated neck pain is considered to be the fourth most frequent cause of disability with an annual 30% increase in the rate of prevalence. according to the report on global burden of diseases (gbd) 2010, neck pain is ranked 21st in terms overall burden of diseases. musculoskeletal pain in the neck and upper limbs is common; population studies suggest that 6-48% of adults have pain in one of these areas . recently, joint mobilization has proven to be effective, and it is now frequently used in clinics .cervical mobilization combined with thoracic mobilization is recommended as a clinical intervention for neck pain patients with forward head posture ( fhp) rather than cervical mobilization alone. this study has two groups; one will receive cervicothoracic mobilization + conventional treatment and the second will receive conventional treatment for eight weeks.

Eligibility criteria:
inclusion criteria: 1. age between 20-50 years . 2. participants will included if their cva less than 48° ( ssa less than 52°) , as above these values are considered normal and thoracic kyphosis (with flexicurve angle more than 45 degrees) . 3. subjects who have weakness in deep neck flexors, serratus anterior, middle and lower trapezius and rhomboid muscles and tightness in upper trapezius, levator scapulae, scalene, posterior neck and suboccipital muscles, pectoralis major and minor and sternocleidomastoid muscles. 4. subject complaining of this symptom for more than 3mothes. 5. marking pain intensity score visual analog scale (vas) ≥3 in neck and shoulder exclusion criteria: 1. history of surgery or joint diseases of the spine or shoulder. 2. osteoporosis, or fracture ,cervical instability or any sign those with other contraindications against joint mobilization. 3. individuals with any cervical condition e.g. radiculopathy, cervical rib, whiplash injury and individuals with any neurological/ condition . 4. history of congenital spinal deformity (congenital scoliosis) . 5. any malignancy related to soft tissue and joints . 6. subjects taking analgesics and/or muscle relaxants. 7. pregnancy. 8. being in weight out of the normal range (18 ≥ bmi ≥ 25). 9. cognitive impairment and inability to understand the scale.

Keywords: forward head posture rounded shoulders thoracic kyphosis ucs mobilization
liposomal bupivacaine in rotator cuff repair

Conditions: Rotator Cuff Injury

Summary: to assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.


Eligibility criteria:
inclusion criteria: * undergoing outpatient arthroscopic rotator cuff repair * greater than or equal to 19 years of age at the time of surgery exclusion criteria: * planned operative fixation of the biceps tendon or acromioclavicular joint * opioid use 6 weeks before surgery * gabapentin use 6 weeks before surgery * history of prior shoulder surgery on the operative limb * severe pulmonary dysfunction * diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s) * history of radicular pain or neuropathy in the operative limb * patients who are currently incapacitated for medical decision making
a study to evaluate immunogenicity of intramuscular full-dose and intradermal fractional dose of ipv

Conditions: Poliomyelitis

Summary: the study will assess and compare the immune response to full-dose inactivated polio vaccines (ipv) via intramuscular (im) administration and of the fractional dose of inactivated poliovirus vaccine (f-ipv) via intradermal (id) administration, in different schedule combinations in the expanded program on immunization (epi) primary series.

this study prioritizes comparisons involving two-dose regimens recently recommended by the world health organization (who) strategic advisory group of experts on immunization (sage) and pan american health organization (paho) in response to global ipv supply shortages 21. furthermore, the study will provide data on the comparative humoral immunogenicity of various schedules to inform polio immunization policy for the post-eradication era. the study population will include infants in dominican republic and panama. absence of wild and circulating vaccine derived polioviruses along with the lack of regular supplementary immunization activities (sias) in the latin america region provide an ideal epidemiologic setting to study polio vaccine immunogenicity. infants will receive two or three doses of full-dose ipv im or f-ipv id, in two schedules (10, 14 and 36 weeks and 14 and 36 weeks). immunological and safety assessments will be made after one dose, two doses and three doses. a total of 773 infants will be enrolled and distributed into 4 groups, according to a randomization scheme. during the study period, infants will be administered other concomitant vaccines according to the national schedules of the participating countries, but the effect, if any, of the concomitant administration on ipv immunogenicity will not be assessed. optimum immunogenicity expected from the dose(s) of ipv in the post-eradication era will have to be balanced with the cost and supply constraints of ipv. this study will be critical to determine how many doses of ipv and which schedule are optimal for the post-eradication era after the global cessation of oral polio vaccine (opv) use.

Eligibility criteria:
inclusion criteria: 1. infants of 6 weeks of age (-7 to + 7 days) on date of enrollment. 2. healthy, as assessed from medical history and physical examination by a study physician, 3. written informed consent obtained from parents or legal representatives who have been properly informed about the study and are able to comply with planned study procedures. exclusion criteria: 1. vaccinated with any poliovirus vaccine prior to inclusion, 2. a household contact with opv vaccination history in the past 4 weeks, 3. hiv infection or pharmacologic immunosuppression, 4. known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde), 5. uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections, 6. acute severe febrile illness on day of vaccination deemed by the investigator(s) to be a contraindication for vaccination, 7. not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).
lidocaine spray 10% versus oral ibuprofen tablets in pain control during copper intrauterine device insertion

Conditions: Lidocaine Toxicity

Summary: the intrauterine contraceptive device (iud) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper iud (a plastic t-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due to its long-term effectiveness, safety and affordability . inconsistent use and discontinuation of contraceptives are major causes of unintended pregnancy . the failure rate of the patch or ring is 20 times higher than that of long acting reversible contraceptives (larcs) . increasing acceptability and use of larc methods like the intrauterine device (iud) is an important strategy to reduce the risk of unintended pregnancy

the aim of this study is to this study is designed to compare between lidocaine spray 10% and oral ibuprofen as an adequate method for decreasing pain during copper intrauterine contraceptive device insertion . research question: which of both drugs ( local lidocaine spray 10% or oral ibuprofen tab.) is more effective in decreasing pain during iud insertion ? research hypothesis in this current study, we hypothesize that using of local cervical lidocaine spray 10% prior to iud insertion will decrease the pain more effectively than ibuprofen tablet 400 mg.

Eligibility criteria:
inclusion criteria: -multiparous women in 3rd to 5th day of menstrual cycle 2- women who were 6 weeks postpartum or if recently pregnant. 3- accept to participate and provide consent exclusion criteria: * • a contraindication for iud use such as a gynecological malignancy , sexually transmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding. * suspicion of pregnancy . * allergy to lidocaine or ibuprofen . * copper allergy . * any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis , and submucous myoma. * a psychological or neurological disorder associated with altered pain sensation. * mirena insertion. * nulliparity. * history of failed intrauterine device insertion (uterine perforation, acute expulsion).
efficacy of platelet rich plasma injections in patients with adhesive capsulitis of the shoulder

Conditions: Adhesive Capsulitis of Shoulder; Adhesive Capsulitis; Frozen Shoulder

Summary: this study was done to investigate whether platelet rich plasma(prp) injections are effective in the management of adhesive capsulitis of the shoulder(ac).patients were randomized to 2 groups, and one group took prp injections for 3 times every two weeks, while the other group took saline injections in same frequency and volume. a standardized exercise programme was also applied to all patients. patients were then evaluated with shoulder pain and disability index(spadi), visual analogous scales for pain and disability, ranges of movements and use of analgesics in before, after and 3rd month of the therapy.


Eligibility criteria:
inclusion criteria: * being over 18 years old and having a shoulder pain with restriction for 3 months at least, and 9 months at most(pain vas being \>40 mm, and loss of rom for affected side more than %25 of unaffected side). exclusion criteria: * subjects were excluded if they had uncontrolled diabetes, active inflammatory diseases, ongoing pregnancy, severe anemia, psychiatric diseases that may affect compliance or cancer. patients who had a history of trauma, recent injection therapies(\<3 months), surgery or allergy to local anaesthetics, or signs of complex regional pain syndrome, local infections or use of non steroidal anti-inflammatory drugs throughout the study were also excluded.
metric: measurement, education and tracking in integrated care

Conditions: Depression

Summary: the proposed study seeks to establish the feasibility of universal screening for depression in an adult primary care safety net setting, measure the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among hispanics, and implement a measurement-based integrated care (mbic) model with collaborative, multi-disciplinary treatment and culturally tailored care management strategies.

specific aim 1: examine the specific effects of a depression education fotonovela (def) to increase knowledge of depression, reduce stigma and increase engagement in depression treatment among hispanic patients. specific aim 2: evaluate the impact of measurement-based integrated care (mbic) for the treatment of depression in one community-based federally qualified health centers (fqhc) in north texas whose patient population is majority hispanic. specific aim 3: examine the feasibility of universal screening and accurate detection of depression among adult primary care patients utilizing innovative ipad depression screening technology.

Eligibility criteria:
inclusion criteria: * adult primary care patients * hispanic * meets diagnostic criteria for depression exclusion criteria: * currently in treatment for depression
mobile-assisted cognitive behavior therapy for negative symptoms in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this clinical trial will test a combined group therapy plus mobile cognitive behavioral therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order to change motivational negative symptoms linked to defeatist attitudes.

the primary purpose of this project is to test whether a psychosocial intervention, cognitive behavioral social skills training (cbsst) combined with a smartphone-based cognitive-behavioral therapy for negative symptoms called, mobile-assisted cognitive behavioral therapy for negative symptoms (mcbtn) can reduce defeatist performance attitudes in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms.the project will also identify the optimal dose to engage the defeatist attitude target. pupillary responses, an objective psychophysiological biomarker of effort, will be recorded during a cognitive task as a secondary outcome to determine its potential as an end point in clinical trials of motivation and effort.

Eligibility criteria:
inclusion criteria: * dsm-5 diagnosis of schizophrenia or schizoaffective disorder. * meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three cains motivation and pleasure domains (mean of 2 -moderate- or greater for items averaged within the social, work or recreational domains) at the beginning and end of a 2-week evaluation phase. * moderate-to-severe defeatist attitudes (dpas \> 50). * ≥ 6th grade reading level on the wide range achievement test-4 reading subtest (needed for reading treatment manual consumer workbook). * clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0). exclusion criteria: * prior cbt in the past 2 years. * greater than moderate panss positive symptoms (p1-delusions, p2- disorganization, p3-hallucinations, or p6-suspiciousness - any item \>5). * severe depression on the calgary depression scale for schizophrenia (cds \>8). * extrapyramidal symptoms (simpson-angus scale \>7). * ocular damage, disease, surgery or medications that affect pupil dilation. * dsm-5 alcohol or substance use disorder in past 3 months. * level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness). * unable to adequately see or manually manipulate the mobile device.

Keywords: schizophrenia cbsst mobile cbt negative symptoms